Expired Study
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Boston, Massachusetts 02215


Purpose:

This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with recurrent aggressive non-Hodgkin's lymphomas. SECONDARY OBJECTIVES: I. To evaluate the duration of response and progression free survival of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas. II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas. III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess influence of monooxygenases polymorphisms and MDR on pharmacokinetics. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.


Criteria:

Inclusion Criteria: - Patients must have histologically confirmed recurrent de novo or transformed diffuse large B cell lymphoma (DLBCL) or one of its variants according to WHO classification (centroblastic, immunoblastic, T-cell/histiocyte rich and anaplastic variants) - Patients must have no CNS involvement - ECOG performance status must be 0 or 1 - Patients must have measurable disease as defined in section 6 assessed within 4 weeks of registration - Patients must not have been previously treated with Sorafenib (BAY 43-9006) or other small molecule targeted inhibitors of MAPK signaling intermediates or angiogenesis (e.g. bevacizumab,/Avastin, oral MEK inhibitor CI-1040) - Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent; autologous stem cell transplant is permitted - Patients must not have progressed within 60 days of last therapy - Patients must not have received prior allogeneic stem cell transplant - Patients must not be candidates for potentially curative therapy, such as HSCT, OR must have refused these alternative therapies - Patients must not be receiving any other investigational agents - Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib - Patients must not have uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements - Leukocytes >= 2,000/mm^3 - Absolute neutrophil count >= 1,000/mm^3 - Platelets >= 75,000/ mm^3 - Total bilirubin =< 2.0 X normal institutional limits - AST =< 2.5 X institutional upper limit of normal - ALT =< 2.5 X institutional upper limit of normal - Creatinine within normal institutional limits; creatinine clearance calculated or measured at >= 60 ml/min/1.73m^2 if creatinine level is above institutional limits - PT/INR Within Institutional limits of normal - Patients with underlying hypertension as defined by blood pressures averaging greater than 140/90 on two separate clinic visits are eligible if hypertension has been controlled by standard nonpharmacologic and pharmacologic therapy - Patients must not have active HIV infection, because of possible pharmacokinetic interactions of anti-retroviral therapy with BAY43-9006 - Patients must be physically able to orally ingest tablets - Patients must not have any evidence of bleeding diathesis - Patients must not be taking the cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine and phenobarbital), rifampin or St. John's Wort - Women must not be pregnant or breast-feeding because the side effects of BAY43-9006 on developing embryos and nursing infants are unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy Exclusion Criteria: - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception


NCT ID:

NCT00131937


Primary Contact:

Principal Investigator
Sandra Horning
Eastern Cooperative Oncology Group


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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